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Sponsored by: |
ChemoCentryx |
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Information provided by: | ChemoCentryx |
ClinicalTrials.gov Identifier: | NCT00102921 |
The purpose of this research study is to investigate the effects of an investigational medication, called CCX282-B, on safety and on the some of the symptoms of Crohn’s Disease in patients who are experiencing an active flare-up of moderate to severe Crohn’s Disease.
Condition | Intervention | Phase |
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Crohn Disease |
Drug: CCX282-B |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pilot, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety Clinical Activity of CCX282-B in Patients With Moderate to Severe Crohn’s Disease |
Estimated Enrollment: | 70 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | December 2005 |
CCX282-B is being developed as a treatment for inflammatory bowel diseases such as Crohn’s Disease. CCX282-B is a highly potent, orally active, chemokine receptor antagonist whose single target is the G-protein coupled receptor CCR9. The CCR9 receptor is expressed by most T-cells in the thymus as well as in the intestine, and by a small population of T-cells in the peripheral blood. In humans, the CCR9 receptor is implicated in Crohn’s Disease and ulcerative colitis.
Crohn’s Disease is an autoimmune disease involving the entire length of the gastrointestinal tract, but with most manifestations in the terminal small intestine and colon. This condition is characterized by mucosal ulcerations that penetrate deeply into the bowel wall. Sometimes the ulcerative lesions completely penetrate the bowel wall, leading to fistula formation and infectious complications requiring surgical intervention. Patients experience considerable lifestyle disruption and disability from this disease, including diarrhea, abdominal pain, malnutrition, anemia, and repetitive surgeries to remove disease-affected gastrointestinal segments.
ChemoCentryx Protocol CL003_282 is a double-blind, placebo-controlled, parallel group, two stratum, Phase 2A pilot study of the safety, tolerability, immunologic and clinical activity, and population pharmacokinetics of a single dose level of CCX282-B administered daily for four consecutive weeks to patients with active, moderate to severe Crohn’s Disease. The primary immunologic and clinical activity objective of this study is to provide pilot information regarding the immunologic and clinical activity of daily oral doses of CCX282-B in the treatment of moderate to severe Crohn’s Disease, based on changes in the Crohn’s Disease Activity Index (CDAI). Secondary immunologic and clinical activity objectives include evaluation of the effect of CCX282-B on the Inflammatory Bowel Disease Questionnaire (IBDQ) instrument, C-reactive protein (CRP), the endoscopic appearance and biopsy of the colon and terminal ileum, and markers of leukocyte subsets and activation status. The primary safety objective of this study is to evaluate the safety and tolerability of oral doses of CCX282-B in patients with moderate to severe Crohn’s Disease. In addition, blood samples will be collected for evaluation of the population pharmacokinetics of CCX282-B.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Cedars-Sinai Medical Center | |
Los Angeles, California, United States, 90048 | |
United States, Colorado | |
Rocky Mountain Clincal Research | |
Golden, Colorado, United States, 80104 | |
Arapahoe Gastroenterology | |
Littleton, Colorado, United States, 80120 | |
United States, Georgia | |
Atlanta Gastroenterology Associates | |
Atlanta, Georgia, United States, 30342 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Minnesota | |
Mayo Clinic Rochester | |
Rochester, Minnesota, United States | |
United States, New Jersey | |
Comprehensive Clinical Research | |
Berlin, New Jersey, United States, 08009 | |
United States, New York | |
Long Island Clinical Research Associates, LLP | |
Great Neck, New York, United States, 11021 | |
United States, North Carolina | |
Wake Forest Research | |
Raleigh, North Carolina, United States, 27612 | |
United States, Ohio | |
University Hospitals of Cleveland, Div of Gastroenterology | |
Cleveland, Ohio, United States, 44106-5066 | |
United States, Tennessee | |
Nashville Medical Research Institute | |
Nashville, Tennessee, United States, 37205 | |
Digestive Disease Clinic | |
Jackson, Tennessee, United States, 38305 | |
United States, Utah | |
Center for Colon Rectal Disease | |
Salt Lake City, Utah, United States, 84124 | |
United States, Virginia | |
University of Virginia Health System, Digestive Health Center of Excellence | |
Charlottesville, Virginia, United States, 22908 |
Study Director: | JJ Kim Wright, PhD | ChemoCentryx, Inc |
Study ID Numbers: | CL003_282 |
Study First Received: | February 4, 2005 |
Last Updated: | March 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00102921 |
Health Authority: | United States: Food and Drug Administration |
Crohn Disease oral medication |
Digestive System Diseases Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases |